Naval Medical Logisitics Command (Nmlc)

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Naval Medical Logisitics Command (Nmlc)

NAVAL MEDICAL LOGISITICS COMMAND (NMLC) GENERAL TERMS AND CONDITIONS FOR FOR-PROFIT ORGANIZATIONS

June 2013

DoDGARs PART 34: http://www.dtic.mil/whs/directives/corres/pdf/32106r_041398/part34.pdf Office of Management and Budget: Open Government Directive http://www.whitehouse.gov/omb/open

ARTICLES 1. Order of Precedence 2. Statutes and Regulations 3. Cost Principles and Audit 4. Access to Records 5. Research Responsibility 6. Amendment of the Award 7. Prior Approvals 8. Preaward Costs 9. Extension of the Expiration Period 10. Unexpended Balance 11. Payments 12. Overpayment and Earned Interest 13. Technical Reporting 14. Financial Reporting 15. Future Funding 16. Option to Extend the Term of the Award 17. Recipient-Acquired Property 18. Supplies 19. Publications and Acknowledgement of Sponsorship 20. Intellectual Property 21. Subawards and Contracts/Subcontracts 22. Security 23. Officials Not to Benefit 24. Military Recruiting on Campus 25. Live Organisms 26. Research Involving Recombinant DNA Molecules 27. Environmental Standards 28. Nondiscrimination 29. Activities Abroad 30. Cargo Preference 31. Preference for U. S. Flag Air Carriers 32. Profit or Fee 33. Claims, Disputes, and Appeals 34. Controlled Unclassified Information 35. Debarment and Suspension 36. Termination or Suspension of the Award 37. Drug Free Workplace

Page 1 of 20 Revised: 21 June 2013 38. Reporting Requirements for Subaward and Executive Compensation 39. Site Visits 40. Financial Assistance Use of Universal Identifier and Central Contractor Registration 41. Trafficking Victims Protection Act 42. Extramural and Intramural Collaboration

1. Order of Precedence

This award is subject to the laws and regulations of the United States. Any inconsistency or conflict in the terms and conditions specified in this award shall be resolved according to the following order of precedence:

(a) The Federal statute authorizing this award or any other Federal statutes directly affecting performance of this award.

(b) Department of Defense Grant and Assistance Regulations (DoDGARs) Part 34, Administrative Requirements for Grants and Agreements with For-Profit Organizations, as appropriate and Appendix A thereto.

(c) These General Terms and Conditions.

(d) Other terms and conditions contained within the award and any attached schedules.

2. Statutes and Regulations

This award is subject to the applicable laws and regulations of the United States that apply to assistance instruments. DoDGARs Part 34 is hereby incorporated into this award by reference. The following, as appropriate, are incorporated into this award:

Federal Acquisition Regulation (FAR) Subpart 31.2 “Contracts With Commercial Organizations”

2 CFR Part 215 “Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations” (formerly OMB Circular A-110)

2 CFR Part 220 “Cost Principles for Educational Institutions” (formerly OMB Circular A-21)

2 CFR Part 225 “Cost Principles for State, Local, and Indian Tribal Governments (formerly OMB Circular A-87)

2 CFR Part 230 “Cost Principles for Non-Profit Organizations” (formerly OMB Circular A-122)

OMB Circular A-133 “Audits of States, Local Governments, and Non-Profit Organizations”

3. Cost Principles and Audit

Applicable to this award and incorporated herein by reference, are the requirements, standards,

Page 2 of 20 Revised: 21 June 2013 and provisions of the DoDGARs, FAR Subpart 31.2, the appropriate Code of Federal Regulations (CFRs), and the appropriate OMB Circulars and attachments thereto, as revised as of the effective date of this award. For purposes of this paragraph, the term "appropriate" is determined by the organizational nature of the Recipient.

In accordance with DoDGARs Part 34, for-profit organizations will use their existing financial management system established for doing business in the commercial marketplace, to the extent that the systems comply with Generally Accepted Accounting Principles and the minimum standards contained in DoDGARs 34.11, 34.16, and 34.17.

Any Recipient that expends $500,000 or more in a year under Federal awards shall have an audit made by an independent auditor in accordance with the requirements of DoDGARs Part 34.16. The recipient shall make the auditor’s report available upon request.

4. Access to Records

Financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of three years from the date of submission of the final expenditure report. The United States Government shall have access to records in accordance with DoDGARs 34.42.

5. Research Responsibility

The Recipient has full responsibility for the conduct of the research activity supported by this award, in accordance with the Recipients’ proposal, and the terms and conditions specified in this award.

Recipients are encouraged to suggest or propose to discontinue or modify unpromising lines of investigation or to explore interesting leads, which may appear during the development of the research. However, they must consult the Grants Officer (GO), through the Grants Officer’s Representative, before deviating from the objectives or overall program of the research originally proposed.

6. Amendment of the Award

Requests by the Recipient to amend an award must be made in writing to the Grants Officer. An award amendment incorporating the request will be unilaterally issued at the discretion of the Grants Officer.

7. Prior Approvals

(a) In accordance with DoDGARs 34.15 prior approval of the following deviations from budget and program plans are required:

(1) The Recipient must receive approval from the GO through the GOR before deviating from the scope or objectives of the research project defined in the award proposal or any subaward. This includes deviations to any approved research protocols.

Page 3 of 20 Revised: 21 June 2013 (2) The Recipient must receive approval from the GO through the GOR before making any subaward, transfer, or contracting out of substantive program performance under an award, unless identified in the proposal that is incorporated as part of the award.

(3) Support for the project may not continue without the active direction of the Principal Investigator approved for, and identified in, this award. If the approved Principal Investigator severs his or her connection with the Recipient or otherwise relinquishes active direction of the project, either permanently or for a significant length of time (three months or more), the Recipient must either:

(i) Appoint a replacement Principal Investigator with the approval of the GO through the GOR, or

(ii) Relinquish the award, in which case the award shall be terminated in accordance with the “Termination” provision in DoDGARs 34.51.

(4) Approval by the GO through the GOR is required for a 25 percent or greater reduction in time devoted to the project, by the approved principal investigator.

(5) A need for additional Federal funding.

(b) In accordance with DoDGARs 34.15, Recipients that are for-profit organizations must consult the GO through the GOR and obtain a written approval from the Grants Officer prior to including any additional costs that require prior approval in accordance with the cost principles for Federal funds and recipients' cost share or match in DoDGARs 34.13 and 34.17.

(c) In accordance with 2 CFR Part 220, Federal Agency approval is granted for the Recipient which is an educational institution to:

Include charges for faculty consulting on sponsored agreements that exceed a faculty member’s base salary rate, but only in unusual cases where:

(1) Consultation is across departmental lines or involves a separate or remote operation; and the consulting work is in addition to the faculty member’s regular departmental load.

(2) Include as direct charges capital expenditures for general purpose equipment or special purpose equipment, but only if the equipment is primarily used in the actual conduct of the research.

(3) Include as direct charges capital expenditures for improvements to equipment that materially increases the equipment’s value or useful life, but only if the equipment is primarily used in the actual conduct of the research.

(4) Include alterations and renovations under $25,000 subject to the following conditions:

(i) The alteration or renovation must be essential to the project supported;

Page 4 of 20 Revised: 21 June 2013 (ii) The facility to be altered or renovated must have a useful life consistent with research purposes and be architecturally and structurally suitable for conversion to the type of space required;

(iii) The space involved must actually be occupied by the project or program;

(iv) The space must be suitable for human occupancy before alteration or renovation work is started, except where the purpose of the alteration or renovation is to make the space suitable for some purpose other than human occupancy (e.g., storage);

(v) If the space is rented, evidence must be provided that the terms of the lease are compatible with the alteration and renovation proposed.

(d) In accordance with 2 CFR Part 230, Federal Agency approval is granted for the Recipient which is a non-profit organization, except those exempted under the Circular, to:

(1) Include as direct charges capital expenditures for general purpose equipment or special purpose equipment, but only if the equipment is primarily used in the actual conduct of the research.

(2) Include as direct charges capital expenditures for improvements to equipment that materially increases the equipment’s value or useful life, but only if the equipment is primarily used in the actual conduct of the research.

(3) Include participant support costs such as stipends, subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees.

(4) Include costs of alterations and renovations under $25,000 subject to the following conditions:

(i) The alteration or renovation must be essential to the project supported;

(ii) The facility to be altered or renovated must have a useful life consistent with research purposes and be architecturally and structurally suitable for conversion to the type of space required;

(iii) The space involved must actually be occupied by the project or program;

(iv) The space must be suitable for human occupancy before alteration or renovation work is started, except where the purpose of the alteration or renovation is to make the space suitable for some purpose other than human occupancy (e.g., storage);

(v) If the space is rented, evidence must be provided that the terms of the lease are compatible with the alteration and renovation proposed.

(e) Prior approval is required for expenditures for individual items of general-purpose equipment and specific purpose equipment costing $5,000 or more, unless identified in the budget that is incorporated as a part of the award.

Page 5 of 20 Revised: 21 June 2013 (f) Prior approval is required for expenditure for foreign travel, unless identified in the proposal that is incorporated as part of the award.

8. Preaward Costs

(a) Recipients may incur preaward costs for up to ninety (90) days prior to the effective date of the award.

(b) Preaward costs as incurred by the Recipient must be necessary for the effective and economical conduct of the project, and the costs must be otherwise allowable in accordance with the appropriate cost principles.

(c) Any preaward costs are incurred at the Recipient’s risk. The incurring of preaward costs by the Recipient does not impose any obligation on the Naval Medical Logistics Command (1) in the absence of appropriations, (2) if an award is not subsequently made, or (3) if an award is made for a lesser amount than the Recipient expected.

9. Extension of the Expiration Period

The Recipient may make a one-time "no cost" extension to the expiration date of the award for a period up to 12 months. The recipient shall notify the Grants Officer, in writing, at least 10 calendar days prior to the expiration date of the award. This one-time extension may not be exercised merely for the purpose of using unobligated balances and the recipient must be in compliance with the terms and conditions of the award.

10. Unexpended Balance

In the absence of any specific notice to the contrary, Recipients are authorized to carry forward unexpended balances of funds received to subsequent funding periods.

11. Payments

(a) Payments will be made on a cost reimbursement basis, which is the preferred payment method. Advance payments may be used in exceptional circumstances subject to the conditions listed at DoDGARs 34.12(b)(2). The payment mechanism will be specified in the award. (b) All payments shall be made by funds transfers to the bank account registered in the Central Contractors Registration (CCR), http://www.ccr.gov. The Recipient agrees to maintain its registration in the CCR including information necessary to facilitate payment via Electronic Funds Transfer (EFT). Should a change in registry or other incident necessitate the payment to an account other than that maintained in CCR, it is the Recipient’s responsibility to notify the Grants Officer and obtain a modification to this award reflecting the change. The Government shall not be held responsible for any misdirection or loss of payment which occurs as a result of a Recipient’s failure to maintain correct/current EFT information within its CCR registration. (c) Wide Area Work Flow (WAWF) has been designated as the Department of Defense standard for electronic invoicing and payment. Electronic submission of payment requests requires the Recipient to register in WAWF and have the appropriate CAGE code activated. The

Page 6 of 20 Revised: 21 June 2013 Recipient’s CCR Electronic Business Point of Contact (EBPOC) is responsible for activating the CAGE code in WAWF by calling 1-866-618-5988. Once the Recipient’s CAGE code is activated, the CCR EBPOC will self-register in WAWF (https://wawf.eb.mil) and follow the instructions for group administrator.

12. Overpayment and Earned Interest

Overpayment: Within ninety (90) days after the end date of the award, any overpayment of funds provided by the award shall be remitted to the Contract Specialist cited in the award, by check made payable to the US Treasury. An overpayment represents the difference between allowable actual expenditures and total disbursements received by the Recipient.

Earned Interest: Recipients who meet the conditions in DoDGARs 34.12(b)(2)(iv) are required to deposit funds advanced under this award in an interest bearing account. Interest earned on such account, shall be remitted annually to the Department of Health and Human Services, Payment Management System, P.O. Box 6021, Rockville, MD 20852, by check made payable to the Treasury of United States.

13. Technical Reporting

Technical reporting requirements are outlined in the award.

14. Financial Reporting

The recipient shall submit on a quarterly basis a Standard Form 425, Federal Financial Report. A final report will also be required after the completion of the award. Each report shall be submitted to the Contract Specialist cited in the award.

15. Future Funding

The Government’s financial obligation is limited to the amount shown as Block 15G of the award document. NMLC does not amend awards to provide additional funds for such purposes as reimbursement for unrecovered indirect costs resulting from the establishment of final negotiated rates or for increases in salaries, fringe benefits, and other costs.

16. Option to Extend the Term of the Award

If an option is indicated in the award document, the Government may require the continuation of the research in accordance with the terms provided in the award.

17. Recipient-Acquired Property

Title to all non-expendable tangible personal property purchased under the award shall conditionally vest in the Recipient, unless stated otherwise in the award. The Recipient shall report and dispose of such property as required by DoDGARs 34.20 through 34.23.

18. Supplies

Page 7 of 20 Revised: 21 June 2013 Title and use of supplies are subject to the requirements of DoDGARs Part 34.24.

19. Publications and Acknowledgment of Sponsorship

(a) Publication of results of the research project in appropriate professional journals is encouraged as an important method of recording and reporting scientific information. One copy of each paper planned for publication shall be submitted to the GO and GOR appointed for this award simultaneously with its submission for publication. Following publication, copies of published papers shall be submitted to the GO and GOR. (b) The Recipient agrees that when releasing information relating to this award, the release shall include a statement to the effect that the project or effort undertaken was or is sponsored by the Department of Navy, Naval Medical Research Center. (c) Disclaimer: The Recipient is responsible for assuring that every publication of material (including World Wide Web pages) based on or developed under this award, except scientific articles or papers appearing in scientific, technical or professional journals, contains the following disclaimer: “Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Naval Medical Research Center.” (d) For the purpose of this clause, information includes news releases, articles, manuscripts, brochures, advertisements, still and motion pictures, speeches, trade association proceedings and symposia. (e) Nothing in the foregoing shall affect compliance with the requirements of articles addressing security or classified information.

20. Intellectual Property

Rights in technical data, patents, inventions, and computer software under this award shall be as specified in DoDGARs 34.25.

Patent application and invention disclosure requirements are listed in the award.

21. Subawards and Contracts/Subcontracts

The applicable Federal cost principles for subawards and contracts/subcontracts under this award shall be those applicable to the type of organization receiving the subaward, contract or subcontract. The applicable cost principles are:

2 CFR Part 220 “Cost Principles for Educational Institutions” (formerly OMB Circular A-21)

2 CFR Part 225 “Cost Principles for State, Local, and Indian Tribal Governments (formerly OMB Circular A-87)

2 CFR Part 230 “Cost Principles for Non-Profit Organizations” (formerly OMB Circular A-122)

Federal Acquisition Regulation (FAR) Subpart 31.2 “Contracts With Commercial Organizations” applicable to commercial firms and those nonprofit organizations specifically exempted from the provisions of 2 CFR Part 230.

Page 8 of 20 Revised: 21 June 2013 45 CFR Part 74, Appendix E, for hospitals.

Page 9 of 20 Revised: 21 June 2013 22. Security

The Recipient shall not be granted access to classified information under this award. If security restrictions should happen to apply to certain aspects of the proposed research, the Recipient will be so informed. In the event that the scientific work under this award may either need classification or involve access to or storage of any classified data, the Government shall make a decision on the need to classify, or require such access or storage within 30 days after receipt of a written notice from the Recipient. If the decision is affirmative, the Government may invoke the Termination clause in DoDGARs 32.61 or 34.51, as appropriate.

23. Officials Not to Benefit

No member of or delegate to Congress, or resident commissioner, shall be admitted to any share or part of this award, or to any benefit arising from it, in accordance with 41 U.S.C. 22.

24. Military Recruiting on Campus

Military Recruiting on Campus (DoDGARs 22.520) applies to domestic U. S. colleges and universities. In such cases, the Military Recruiting regulations are incorporated herein by reference.

25. Live Organisms

By accepting funds under this award, the recipient assures that it will comply with applicable provision of the following policies concerning living organisms and will not begin performance of research involving human subjects or using animals until all approvals have been obtained.

(a) For human subjects:

(1) Common Federal Policy for the Protection of Human Subjects codified by the Department of Health and Human Services at 45 CFR 46 Part A, and implemented by the Department of Defense at 32 CFR 219.

(2) DoD Instruction 3216.02 and applicable DON Component policies.

(3) 10 U.S.C. 980, Limitation on use of humans as experimental subjects.

(4) Food and Drug Administration policies and regulations, when applicable.

(b) For animals:

(1) Rules on animal acquisition, transport, care, handling, and use in (i) 9 CFR Parts 1-4, Department of Agriculture rules that implement the Laboratory Animal Welfare Act of 1966 (7 U.S.C 2131-2159, as amended); and (ii) the "Guide for the Care and Use of Laboratory Animals," 1996, published by the National Academy Press, Washington DC.

(2) DoD Instruction 3216.01 and applicable DON Component policies.

Page 10 of 20 Revised: 21 June 2013 (3) Prohibitions on the purchase or use of dogs and cats for certain medical training purposes, in Section 8019 (10 U.S.C. 2241 note) of the Department of Defense Appropriations Act, 1991 (Pub. Law 101-511).

(4) Rules of the Department of Interior (50 CFR Parts 10-14, 17-18, 23) and Commerce (50 CFR Parts 216-227) and other applicable regulations implementing laws and conventions on the taking possession, transport, purchase, sale, export or import of wildlife and plants, including the Endangered Species Act of 1973 (16 U.S.C. 1531-1543); Marine Mammal Protection Act (16 U.S.C. 1361-1384); Lacey Act (18 U.S.C. 42); and Convention International Trade in Endangered Species of Wild Fauna and Flora.

(5) Applicable rules and regulations regarding the use of harmful or dangerous viruses and other similar agents at 21 U.S.C. 154 and 9 CFR 117; and regarding import and exportation, shipment and quarantine at 5 U.S.C. 301; 21 U.S.C. 111-113, 114a, 115-117, 120-126, and 151-158; 9 CFR 71-97 and 122; 42 U.S.C. 216 and 264-272 and 42 CFR 71-72.

26. Research Involving Recombinant DNA Molecules

Any recipient performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules agrees by acceptance of this award to comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules", of July 5, 1994 (59 FR 34496), amended August 5, 1994 (59 FR 40170), amended April 27, 1995 (60 FR 20726), and such later revision of those guidelines as may be published in the Federal Register.

27. Environmental Standards

By accepting funds under this award, the Recipient assures that it will:

Comply with applicable provisions of the Clean Air Act (42 U.S.C. 7401, et seq.) and Clean Water Act (33 U.S.C. 1251, et.seq.), as implemented by Executive Order 11738 [3 CFR, 1971- 1975 comp., p. 799] and Environmental Protection Agency (EPA) rules at 40 CFR Part 15. In accordance with the EPA rules, the recipient further agrees that it will:

Not use any facility on the EPA’s List of Violating Facilities in performing any award that is nonexempt under 40 CFR 15.5 (awards of less than $100,000, and certain other awards, exempt from the EPA regulations), as long as the facility remains on the list.

Notify the awarding agency if it intends to use a facility in performing this award that is on the List of Violating Facilities or that the Recipient knows has been recommended to be placed on the List of Violating Facilities.

Identify to the awarding agency any impact this award may have on: The quality of the human environment, and provide help the agency may need to comply with the National Environmental Policy Act (NEPA, at 42 U.S.C. 4321, et seq.) and to prepare Environmental Impact Statements or other required environmental documentation. In such cases, the Recipient agrees to take no action that will have an adverse environmental impact (e.g., physical disturbance of a site such as breaking of ground) until the agency provides written

Page 11 of 20 Revised: 21 June 2013 notification of compliance with the environmental impact analysis process.

Coastal barriers, and provide help the agency may need to comply with the Coastal Barriers Resource Act (16 U.S.C. 3501, et seq.), concerning preservation of barrier resources.

Any existing or proposed component of the National Wild and Scenic Rivers system, and provide help the agency may need to comply with the Wild and Scenic Rivers Act of 1968 (16 U.S.C. 1271, et seq.).

28. Nondiscrimination

By accepting funds under this award, the Recipient assures that it will comply with applicable provisions of the following national policies prohibiting discrimination:

On the basis of race, color, or national origin, in Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d, et seq.), as implemented by DoD regulations at 32 CFR Part 195. On the basis of sex or blindness, in Title IX of the Education Amendments of 1972 (20 U.S.C. 1681, et seq.).

On the basis of age, in the Age Discrimination Act of 1975 (42 U.S.C. 6101, et seq.) as implemented by Department of Health and Human Services regulations at 45 CFR Part 90.

On the basis of handicap, in Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), as implemented by Department of Justice regulations at 28 CFR Part 41 and DoD regulations at 32 CFR Part 56.

29. Activities Abroad

The Recipient shall assure that project activities carried on outside the United States are coordinated as necessary with appropriate Government authorities and that appropriate licenses, permits, or approvals are obtained prior to undertaking proposed activities. The awarding agency does not assume responsibility for Recipient compliance with the laws and regulations of the country in which the activities are to be conducted.

30. Cargo Preference

The Recipient agrees that it will comply with the Cargo Preference Act of 1954 (46 U.S.C. 1241), as implemented by Department of Transportation regulations at 46 CFR 381.7, which require that at least 50 percent of equipment, materials or commodities procured or otherwise obtained with U.S. Government funds under this award, and which may be transported by ocean vessel, shall be transported on privately owned U.S.-flag commercial vessels, if available.

31. Preference for U. S. Flag Air Carriers

Travel supported by U.S. Government funds under this award shall use U.S.-flag air carriers (air carriers holding certificates under 49 U.S.C. 41102) for international air transportation of people and property to the extent that such service is available, in accordance with the International Air Transportation Fair Competitive Practices Act of 1974 (49 U.S.C. 40118) and the interpretative

Page 12 of 20 Revised: 21 June 2013 guidelines issued by the Comptroller General of the United States in the March 31, 1981, amendment to Comptroller General Decision B138942.

32. Profit or Fee

In accordance with DoDGARs 22.205(b) and DoD policy, no fee or profit may be charged to this award.

33. Claims, Disputes, and Appeals

(a) Recipient Claims.

Recipients shall submit claims arising out of this award to the Grants Officer. Claims shall specify the nature and basis for the relief requested and shall include all data and relevant facts in support of the claim.

(b) DoD Component Claims.

Claims by a DoD Component shall be the subject of a written decision by the Grants Officer.

(c) Alternative Dispute Resolution (ADR).

The Parties shall endeavor to agree upon an ADR technique (such as discussions, mediation, or mini-trial) appropriate to resolve any dispute, and they shall use ADR to the maximum extent practicable.

(d) Grants Officer decisions.

(1) Within 60 calendar days after receipt of a written claim, the Grants Officer shall:

(i) Prepare a written decision, which shall include the basis for the decision, the relevant facts on which the decision is based, and the identity and address of the cognizant Appeal Authority; or

(ii) Notify the Recipient of a date when the decision will be rendered. The notice shall address why additional time is needed and what, if any, additional information is required from the Recipient to adjudicate the claim.

(2) The Grants Officer’s decision is considered final, unless appealed. In the event of an appeal, the Parties shall endeavor to use ADR procedures to the maximum extent practicable.

(e) Formal Administrative Appeals.

(1) Appeal Authority. The Executive Officer, NMLC is the Appeal Authority to decide formal, administrative appeals under this award. If the Executive Officer is unable to serve in this capacity, the Director of Acquisition Management shall so serve.

Page 13 of 20 Revised: 21 June 2013 (2) A Recipient may appeal a Grants Officer’s decision within 90 calendar days of receiving the decision by filing a written notice of appeal with the Appeal Authority and the Grants Officer.

(3) If the Parties elect to use ADR following the Grant Officer’s decision, the remaining portion of the 90-day period for filing notice of appeal shall be tolled during the period running from the date the Parties agree in writing to utilize ADR to the date either (1) an ADR decision is issued or (2) one party notifies the other in writing that it is abandoning the ADR process.

(4) Appeal File. Within 30 calendar days after receipt of the notice of appeal, the Grants Officer shall forward to the Appeal Authority and the Recipient the appeal file, which shall include copies of all documents relevant to the appeal. The Recipient may supplement the file with additional documents it deems relevant. Either Party may supplement the file with a memorandum in support of its position, and the Appeal Authority may request additional information from the Parties.

(5) Decision. The appeal shall be decided solely on the basis of the written record, unless the Appeal Authority decides to conduct fact-finding or an oral hearing on the appeal. Any fact finding or hearing shall be conducted using procedures that the Appeal Authority deems appropriate. The decision of the Appeal Authority shall be final.

(6) Representation. A Recipient may be represented by counsel or any other designated representative in any claim, appeal, or ADR proceeding brought pursuant to this section, as long as the representative is not otherwise prohibited by law or regulation from appearing before the Naval Medical Logistics Command.

(f) Non-exclusivity of remedies.

Nothing in this section including the statement contained in paragraph (e) (5) above is intended to limit a Recipient’s right to any remedy under the law.

34. Controlled Unclassified Information

The parties understand that information and materials provided pursuant to or resulting from this award may be export controlled, sensitive, for official use only, or otherwise protected by law, executive order or regulation. The Recipient is responsible for compliance with all applicable laws and regulations. Nothing in this award shall be construed to permit any disclosure in violation of those restrictions.

35. Debarment and Suspension

Recipients shall comply with all the requirements of DoDGARs Part 25, Subpart C, “Government- Wide Suspension and Debarment (Nonprocurement),” 32 CFR Part 25, Subpart C. The Recipient shall include a similar term or condition in lower-tier covered transactions as required by DoDGARs Part 25, Subpart B, 32 CFR Part 25 (2004).

36. Termination or Suspension of the Award

Page 14 of 20 Revised: 21 June 2013 (a) The Grants Officer may terminate or suspend in part or in whole, this agreement by written notice to the Recipient upon a finding that the Recipient has failed to comply with the material provisions of this agreement, if the Recipient materially changes the objectives of the agreement, or if appropriated funds are not available to support the program. However, the Grants Officer may immediately suspend or terminate the award without prior notice when such action is necessary to protect the interests of the Government.

(b) Additionally, this agreement may be terminated by either party upon written notice to the other party, based upon a reasonable determination that the project will not produce beneficial results commensurate with the expenditure of resources. Such written notice shall be preceded by consultation between the parties. In the event of a termination, the Government shall have a paid-up license in any subject invention, copyright work, data or technical data made or developed under this agreement.

(c) No costs incurred during a suspension period or after the effective date of a termination will be allowable, except those costs which, in the opinion of the Grants Officer, the Recipient could not reasonably avoid or eliminate, or which were otherwise authorized by the suspension or termination notice, provided such costs would otherwise be allowable under the terms of the award and the applicable Federal cost principles. In no event will the total of payments under a terminated award exceed the amount obligated in this award.

37. Drug Free Workplace

By accepting funds under this award, the recipient agrees to comply with the “Government –Wide Requirements for Drug-Free Workplace (Financial Assistance)” requirements specified by DoDGARs Part 26, Subpart B (or Subpart C, if the recipient is an individual) of 32 CFR Part 26 (2004), which implements sec.5151-5160 of Drug-Free Workplace Act of 1988 (41 U.S.C. 701,et seq.).

38. Reporting Requirements for Subaward and Executive Compensation

The Recipient shall report on first –tier subawards and executive compensation in accordance with the Federal Funding Accountability and Transparency Act (FFATA) of 2006 and associated 2008 amendments. Reporting is required for awards equal to or over $25,000. If the initial award is below $25,000 but subsequent modifications result in a total award equal to or over $25,000, the award will be subject to the reporting requirements, as of the date the award exceeds $25,000. If the initial award equals or exceeds $25,000 but funding is subsequently deobligated such that the total award amount falls below $25,000, the award continues to be subject to the reporting requirements of the Transparency Act.

39. Site Visits

The Grants Officer, or authorized representative, has the right at all reasonable times to make site visits to review project accomplishments and to provide such technical assistance as may be required. If any site visit is made by the Government representative on the premises of the Recipient or Subrecipient, the Recipient shall provide, and shall require its Subrecipients to provide, all

Page 15 of 20 Revised: 21 June 2013 reasonable facilities and assistance for the safety and convenience of the Government representatives in the performance of their duties. All site visits and evaluations shall be performed in such a manner as will not unduly interfere with or delay the work.

Page 16 of 20 Revised: 21 June 2013 40. Financial Assistance Use of Universal Identifier and Central Contractor Registration

Recipient and first-tier subrecipients shall have Dun and Bradstreet Data Universal Numbering System (DUNS) numbers and maintain current registrations in the Central Contractor Registration (CCR) data base.

41. Trafficking Victims Protection Act

Trafficking in persons.

a. Provisions applicable to a recipient that is a private entity.

l. You as the recipient, your employees, subrecipients under this award, and subrecipients' employees may not--

i. Engage in severe forms of trafficking in persons during the period of time that the award is in effect; ii. Procure a commercial sex act during the period of time that award is in effect; or iii. Use forced labor in the performance of the award or subawards under the award.

2. We as the Federal awarding agency may unilaterally terminate this award, without penalty, if you or a subrecipient that is a private entity--

i. Is determined to have violated a prohibition in paragraph a.1 of this award term; or ii. Has an employee who is determined by the agency official authorized to terminate the award to have violated a prohibition in paragraph a.1 of this award term through conduct that is either-- A. Associated with performance under this award; or B. Imputed to you or the subrecipient using the standards and due process for imputing the conduct of an individual to an organization that are provided in 2 CFR 180, "OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement)," as implemented by our agency at 2 CFR part 1125.

b. Provision applicable to a recipient other than a private entity. We as the Federal awarding agency may unilaterally terminate this award, without penalty, if a subrecipient that is a private entity--

l. Is determined to have violated an applicable prohibition in paragraph a.1 of this award term; or

2. Has an employee who is determined by the agency official authorized to terminate the award to have violated an applicable prohibition in paragraph a.1 of this award term through conduct that is either--

i. Associated with performance under this award; ii. Imputed to the subrecipient using the standards and due process for imputing the conduct of an individual to an organization that are provided in 2 CFR part 180, "OMB Guidelines to

Page 17 of 20 Revised: 21 June 2013 Agencies on Governmentwide Debarment and Suspension (Nonprocurement)," as implemented by our agency at 2 CFR part 1125.

c. Provision applicable to any recipient.

l. You must inform us immediately of any information you receive from any source alleging a violation of a prohibition in paragraph a.1 of the award term.

2. Our right to terminate unilaterally that is described in paragraph a.2. or b. of this section:

i. Implements section 106(g) of the Trafficking Victims Protection Act of 2000 (TVPA), as amended (22 U.S.C. 7104(g)), and ii. Is in addition to all other remedies for noncompliance that are available to us under this award.

3. You must include the requirements of paragraph a.1 of this award term in any subaward you make to a private entity.

d. Definitions. For the purpose of this award term:

l. "Employee" means either:

i. An individual employed by you or a subrecipient who is engaged in the performance of the project or program under this award; or ii. Another person engaged in the performance of the project or program under this award and not compensated by you including, but not limited to, a volunteer or individual whose services are contributed by a third party as an in-kind contribution toward cost sharing or matching requirements.

2. "Forced labor" means labor obtained by any of the following methods: the recruitment, harboring, transportation, provision, or obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purpose of subjection to involuntary servitude, peonage, debt bondage, or slavery.

3. "Private entity":

i. Means any entity other than a State, local government, Indian Tribe, or foreign public entity, as those terms are defined in 2 CFR 175.25. ii. Includes:

A. A nonprofit organization, including any nonprofit institution of higher education, hospital, or tribal organization other than one included in the definition if Indian Tribe at 2 CFR 175.25(b). B. A for-profit organization.

4. "Severe forms of trafficking in persons," "commercial sex act," and "coercion" have the meanings given at section 103 of the TVPA, as amended (22 U.S.C. 7102).

Page 18 of 20 Revised: 21 June 2013 Page 19 of 20 Revised: 21 June 2013 42. Extramural and Intramural Collaboration

Research and development which involves awarding to extramural recipients (Non-Government) with collaboration, in part from intramural entities (Government) shall adhere to the following guidance contained herein at subparagraphs (a) - (c).

(a) Intramural costs shall not be included and contributory to direct or total cost on proposed extramural efforts. Rather these pieces shall be identified and broken out in separate costs within extramural proposals, as to avoid duplicative expenses to the Government.

(b) The extramural portion will be funded via an assistance agreement through NMLC; the intramural portion will be funded directly, via a Military Interdepartmental Purchase Request (MIPR) or some other type of Funding Authorization Document (FAD) between the Government entities.

(c) The use of Cooperative Research and Development Agreements (CRADAs) as a mechanism to provide funding to Government entities, in collaboration on Non- Governmental efforts will be prohibited, unless specified otherwise, in all awards resultant from any NMLC Broad Agency Announcements (BAAs) or Program Announcements (PAs).

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Page 20 of 20 Revised: 21 June 2013

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